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Cooperation in the North Zone

Denmark, Estonia, Finland, Latvia, Lithuania, Sweden and Norway cooperate on evaluation of applications for authorisation of plant protection products.

This cooperation is part of the implementation of Regulation No. 1107/2009. The purpose is to share the work and harmonise the evaluations.

A guidance document on procedures and evaluation principles for the North Zone has been developed. In addition separate guidance on risk assessment for birds and mammals and efficacy has been developed. See links below. The documents are updated when needed.

Latest version from May 2017:

Northern zone guidance document version 6.0 

This guidance document is mandatory from the 1st of November 2017.

Previous version:

Guidance document on work-sharing in the Northern zone - version 5.0.pdf

This guidance document replaces the version of April 2016, and was mandatory from the 1st of October 2016.

Guidance document on work-sharing in the Northern zone, version 4.0.
This guidance document replaces the version of April 2014, and was mandatory from the 1st of January 2016.

Guidance document on work-sharing in the Northern zone, version 3.0.

This guidance document replaced the version from April 2013 and was mandatory from 1 January 2015.

Guidance document on work-sharing in the Northern zone, version 2.0. 
This guidance document replaced the version of 1st July 2011 and was to be applied from 1st of October 2013. 

 

Risk assessment for birds, mammals and plant protection products

The risk assessment of pesticides with regard to birds and mammals is based on the EU guidance documents.

Sometimes there may be a need to perform a 'higher tier' risk assessment for particular Nordic conditions. To this end, a guidance document has been prepared describing the birds and mammals of relevance in the Nordic Zone and presenting scenarios for a series of use areas. The document is linked to a spreadsheet to be used in connection with the scenarios.

The guidance development was supported by funding from the Nordic Council of Ministers.

Higher tier risk assessment for birds and mammals, April 2017

Spreadsheet for Birds and Mammals from April 2017.

Previous guidance:

Higher tier risk assessment for birds and mammals, April 2016

Higher tier risk assessment for birds and mammals, May 2015.

Guidance on risk assessment for Birds and Mammals, April 2014.

Guidance on risk assessment for birds and mammals, April 2013.

Previous spreadsheet:

Spreadsheet for Birds and Mammals from May 2016.

Spreadsheet for Birds and Mammals from January 2015.

Spreadsheet for birds and mammals, from April 2013.

 

Evaluation of efficacy in the North Zone

The document aims to specify the requirements for documentation wherever possible. The references in the text apply to Annex III to Directive 93/71/EEC.

The specifications on requirements for documentation and number of trials are intended as a guide to the common requirements for documentation in connection with efficacy evaluation in the North Zone. For the purpose of this document the North Zone is defined as follows; Denmark, Estonia, Finland, Latvia, Lithuania, Norway and Sweden.

 

Guidance on efficacy evaluation in the North Zone.